ME Action article, 6 March 2016: Ten organisations call for PACE data release, AYME refuses

Ten organisations so far have joined ME/CFS patient Clark Ellis’s call to Queen Mary University of London (QMUL) to release data from the PACE trial but one group has refused.

In early February, Mr Ellis asked seven major UK ME/CFS charities to write to ask QMUL to abandon their tribunal appeal against the UK Information Commissioner’s decision that they should release the data to a patient who had requested it.

Six responded — the ME Association, Action for ME, ME Research UK, Invest in ME, the Tymes Trust and the 25% ME Group. In addition, Hope 4 ME & Fibro NI, the Welsh Association of ME & CFS Support, the Irish ME Trust and Dutch organisation Groep ME Den Haag have joined them.

However, one group that he contacted — the Association of Young People with ME (AYME) — has refused to join the call. Mr Ellis said that the move “flies in the face of patients’ interests”.

AYME made their decision at a board meeting on 3 March but have made no public announcement. They emailed Mr Ellis, saying, “The QMUL data has already been released to and reanalysed by the Cochrane Collaboration (perhaps the most rigorous of research teams), which came to the same conclusion as the original researchers.”

AYME’s statement appears to indicate some confusion about the nature of the Cochrane Collaboration, which describes itself as an “independent network” of researchers and others, who can set up teams following Cochrane’s guidelines. The team who received the individual patient data from the PACE trial included all three of PACE’s principal investigators — Professors Peter White, Michael Sharpe, and Trudie Chalder. One of the team’s meetings was funded by Professor White’s academic fund. The results of their reanalysis have not been published.

In their email to Clark Ellis, AYME also stated, “This release to a bona fide researcher who has an ethical duty of care for the data complies with a condition of Medical Research Council (MRC) funding. For the same reasons, it remains open to other bona fide researchers to request the data, subject to the same ethical undertakings. Therefore there is no requirement for AYME to write to QMUL and we will not be doing so… No further comment will be made regarding our position on this matter.”

However, independent scientists who have requested the anonymised raw data have been refused by QMUL. They include geneticist Professor Ron Davis of Stanford University, biostatistician Professor Bruce Levin of Columbia University and psychologist Professor James Coyne of Pennsylvania University.

AYME’s lead medical advisor is Dr Esther Crawley, who is principal investigator for the MAGENTA study of graded exercise therapy for young people, dubbed “PACE for children” by the Welsh Association of ME & CFS Support. She has described PACE as “well conducted”.

Dr Crawley was also principal investigator on the controversial SMILE trial of the Lightning Process for children with ME/CFS. The Lightning Process is described by Phil Parker, its inventor, as a programme of “gentle movement” and “mental exercises” but has been dismissed by psychologist Professor James Coyne as “quackery justified by pseudoscience”. While other charities objected to plans for the study and called it “unethical”, its protocol was developed with the “active participation” of AYME.

Clark Ellis said, “I’m disappointed to see an ME/CFS charity letting patients down in this way. All the rest have been fantastic. I think it’s important to look at why AYME are acting differently from everyone else.”

He encourages patients outside the UK to contact their own national organisations and ask them to write to QMUL.